ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.— 510(k) K871543

Name: FDA 510(k) clearance K871543
Creator: U.S. Food and Drug Administration
Published: 1987-06-22

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K871543 for ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU., Substantially Equivalent on 1987-06-22. Applicant: Catachem, Inc.. Device class: 2.

Clearance details

Applicant: Catachem, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1987-04-20
Decision date: 1987-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

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